Thursday, October 30, 2008

The East London Borough of Redbridge is considering a new policy which would prohibit anyone who smokes from becoming a foster parent. The Redbridge Council Cabinet will meet on Tuesday to vote on the proposed policy, which would go into effect in January 2010.

According to an article in the Daily Mail: "Smokers could be completely banned from fostering children under controversial proposals branded health 'fascism' by opponents. Redbridge in East London is believed to the first council in the country to consider a total ban on foster carers who smoke, no matter how old the child they want to look after. It says the tough rules are needed to protect children from the effect of passive smoking, and to stop them taking up the habit from carers who they see as their role models. ...fostering organisations said they did not believe occasional smokers should be banned, at a time when there is a national shortage of 10,000 foster carers."

According to the article: "Michael Stark, the council's cabinet member for children's services, ... said he was acting on NHS advice which said those who breathe in second-hand smoke are at the same risk as those who smoke themselves...".

A professor at Cancer Research UK was quoted as stating that childhood exposure to secondhand smoke causes childhood cancer: "Director of tobacco studies at Cancer Research UK, Professor Richard West, said: 'Smoking around children can exacerbate asthma, increase childhood cancers and make them more susceptible to respiratory problems.'"

Several groups expressed opposition to the policy: "Neil Rafferty of smokers' rights group Forest branded those who wanted to ban smokers from being carers as 'health fascists'. 'There are many millions of smokers who would make brilliant foster parents,' he said. 'It's really troubling. Next they'll be banning obese people for setting a bad example. Where will it end?'"

"The Fostering Network, which represents most of Britain's carers, advised that a ban should only be placed on carers of children under the age of five - advice that most councils follow."

"A spokesman for the Department for Children, Schools and Families said: 'The health and well-being of looked-after children is paramount and we do, of course, want children to be protected from the harmful effects of smoking. Whilst our regulations do not ban smokers from becoming foster carers, smoking is certainly an issue which we would expect fostering providers to take into account as part of the approvals process.'"

The Rest of the Story

The idea of banning smokers from being foster parents because they may set a bad example for their children is a dangerous one. While foster children should be protected from harmful behavior, it is not the appropriate role of the fostering agencies to cast moral judgments on the legal behaviors of potential parents, especially when the issue is the assumption of health risks by that individual.

As the spokesperson for Forest pointed out, this is conceptually a slippery slope. The same argument could be applied to ban obese people from becoming foster parents. It could also be applied to deny the right to foster children to individuals based on religion or sexual orientation. It is indeed scary to think about where this could lead next.

Given the apparent shortage of foster parents in England, it is unfortunate that smokers will categorically be denied the opportunity to foster children, even if they are potentially loving, caring, responsible parents and especially if they are willing to minimize their children's smoke exposure by, for example, smoking outside.

The argument that this policy is necessary in order to protect children from secondhand smoke does not hold water. The policy applies to all smokers, even if they agree to refrain from smoking in the presence of their children. It applies even to occasional smokers, who might only smoke when their children are not around or might even smoke only when they are outside of their home.

While a sensible policy would take all of these factors into account as part of the decision, a categorical rejection of any individual who smokes appears to be motivated as much by a disdain for smokers as by a legitimate concern for the well-being of the children. After all, with a severe shortage of foster parents, is it really better to deny children foster care or keep them waiting longer just to avoid having to place them with an individual who has made the decision to smoke and even if that individual agrees to refrain from smoking in the child's presence?

Does it make sense to categorically deny the opportunity to be a foster parent to all smokers, even when the children in question may be adolescents who are much less susceptible to the respiratory health effects of secondhand smoke (e.g., pneumonia, bronchitis) and who may even smoke themselves? Can you imagine a 16-year-old smoker being told she has to wait longer to be placed in foster care because the prospective parent is a smoker and she needs to be protected from secondhand smoke, even as she herself puffs on a cigarette?

It is also unfortunate that the policy is being justified based on false scientific claims. It is untrue that "those who breathe in second-hand smoke are at the same risk as those who smoke themselves." I have thoroughly debunked this myth, which is still being disseminated by many anti-smoking groups.

The claim that secondhand smoke exposure causes childhood cancer is unsupported by the bulk of the scientific evidence, and for this reason, the California EPA and the U.S. Surgeon General have not linked tobacco smoke exposure to childhood cancer (even though the Surgeon General told the public that breathing in tobacco smoke for 30 minutes sets the cancer process in motion).

Ironically, Forest's prediction that banning obese people from being foster parents will be next does not appear to be too far off the mark. An article in yesterday's Daily Mail reports thata social services agency in England has taken seven children away from their parents because the children are obese. This is scary, especially because obesity is largely hereditary and obese parents are much more likely to have obese children. They may, in fact, not be able to control their children's weight. It is scary to think that the government may take away your children for a factor over which you as a parent have no control!

Wednesday, October 29, 2008

In a letter to the editor published in USA Today on October 22, John Nothdurft - a legislative specialist with the Heartland Institute in Chicago - argues that complete campus-wide smoking bans are not only an example of unwarranted political correctness, but that they also introduce safety concerns, as many students leave campus to smoke.

Nothdurft writes: "The recent bans on smoking across entire campuses at state-owned colleges in Pennsylvania are political correctness overkill. The 128-acre Clarion University is one of the newest sites in Pennsylvania for such draconian smoking rules ... In addition to protecting individual rights, legitimate safety ramifications should be taken into consideration before smoking bans are enacted. Clarion University's ban will force hundreds of students, many of whom don't have cars, to hike outside the relative safety of a college campus to partake in the legal act of smoking. This move by the Pennsylvania State System of Higher Education is another example of a governmental entity trying to gain political favor by branding smokers as second-class citizens. The ban puts hundreds of students unnecessarily at risk when accommodations could easily be made."

In the mean time, efforts to ban smoking on entire college campuses continues to spread. An anti-smoking group at Johns Hopkins University recently announced its goal of achieving a "total smoking ban on campus."

Advocates at the University of Missouri are working to achieve a complete, campus-wide smoking ban, arguing that: "Even the seconds of walking past someone near a building entrance has a certain degree of harm."

The Rest of the Story

In my opinion, campus-wide smoking bans are draconian policies because they are far beyond what is necessary to protect nonsmokers from secondhand smoke. The only legitimate reason to institute such policies would be to protect smokers from themselves, making the policy purely paternalistic and in my mind unjustified.

In fact, anti-smoking advocates are at such a loss to defend the paternalistic nature of these policies that they seem to be resorting to distortion and exaggeration to argue that these policies are actually needed to protect people from significant hazards posed by secondhand smoke. The advocate at the University of Missouri had to resort to the argument that even a few whiffs of smoke are harmful and cannot be tolerated.

If a university truly felt that it was within its mission to regulate the behavior of students on its campus so that they could only engage in healthy behaviors, then it would want to not only ban smoking, but also the use of alcohol, the consumption of trans-fats and junk foods, the consumption of more than a certain number of calories a day, and the practice of unsafe sex. Obviously, we would view such a policy as an undue intrusion into personal autonomy. But if it is intrusive to regulate a person's diet, then it is also intrusive to regulate a person's decision to smoke, which is also a legal behavior.

I think anti-smoking advocates realize this and therefore are distorting and exaggerating the science on the effects of secondhand smoke in order to justify these policies.

While I would oppose these policies even if they presented no safety concerns, there are some legitimate concerns. At Fullerton College in California, there have been a number of fires caused by students throwing lighted cigarettes in trash cans when they saw a safety officer approaching. One fire apparently occurred in a bathroom.

That these policies are non-enforceable is yet another argument against them, but my opinion would not change even if they could be enforced.

These policies clearly cross the line from being ones that protect health to ones that make anti-smoking advocates feel good but do little other than to stigmatize smokers.

Monday, October 27, 2008

New Study Claims to Find Support for Ban on Smoking in Homes with Children, But Conclusion was Pre-Determined

A new study published online ahead of print in the American Journal of Public Health purports to provide an ethical analysis of policies that ban smoking in homes in which children are present. Based on an analysis of the implications of such a policy for the principles of autonomy and nonmaleficence, the authors conclude that smoke-free home policies are justified in order to protect children from harm (see: Jarvie JA, Malone RE. Children’s secondhand smoke exposure in private homes and cars: an ethical analysis. Am J Public Health, December 2008).

In analyzing smoking bans in homes with children from the perspectives of autonomy and nonmaleficence, the authors conclude: “Restricting smoking by adults in cars or homes in which children are present is the most ethically justifiable position, minimizing paternalism, while respecting autonomy and emphasizing nonmaleficence toward children.”

However, in their analysis, the authors acknowledge the following: “lack of knowledge, lack of resources, and economic or psychosocial burdens may challenge the definition of many adult behaviors, including smoking, as maleficent or nonbeneficent. For example, a single parent addicted to nicotine and in early recovery from heroin addiction who lives in public housing with smoke-free common areas, located in a neighborhood with high rates of violent crime, may decide that smoking inside with the window open is safer for her young children than risking the trek to find a place to smoke outside. This journey might expose her family to neglect or violence, or expose the mother to drugs during her still-tenuous recovery. In some cases, therefore, it may be argued that the immediacy of addressing other injurious factors, including the context within which adult smoking occurs, may take precedence.”

Nevertheless, the authors conclude: “Analogous to the process of regulating public secondhand smoke, policy for private domains may serve most effectively to enhance changes in social norms. Creating a norm of unacceptability for childhood secondhand smoke exposure poses no threat to adult autonomy.”

The Rest of the Story

To the careful reader, this paper is an example of the justification of a pre-determined conclusion regarding a policy via a purportedly objective policy analysis. This story demonstrates that a strong bias on the part of anti-smoking researchers is present not only in research, but in policy analysis as well.

Here, the authors have apparently reached a pre-determined conclusion that smoke-free home policies are justified to protect children and attempted, post-hoc, to supply some sort of ethical analysis that would justify this policy. Their attempt to do so is weakly disguised, however, as it is easily apparent that the authors are not actually allowing their opinions to be informed by the results of their own analysis.

Most notably, the authors established – from their analysis – two key points in the paper:

First, the authors established that banning smoking in homes with children present does not necessarily represent a policy of nonmaleficence, because there are situations in which the smoking parent may and family may be subject to greater risks, such as that from exposure to drugs, neglect, or violence. The authors present precisely such a situation: in this situation, the authors themselves argue that choosing to smoke inside the home with the window open might be an option associated with less risk to the family than observing the law and going outside to smoke.

Second, the authors established that banning smoking in homes with children present does not protect individual autonomy and in fact may interfere with the ability of a parent to make a wise decision that minimizes overall risk for the family. The authors actually present an example which illustrates a situation where a parent would be subjecting the family to greater risk by following a policy of not smoking in the home.

However, in both cases, the authors ignore their own arguments and present a conclusion which is inconsistent with the arguments that they themselves advance. First, they conclude that “Restricting smoking by adults in cars or homes in which children are present is the most ethically justifiable position, minimizing paternalism, while respecting autonomy and emphasizing nonmaleficence toward children.” But as they have themselves shown, such a policy may neither emphasize nonmaleficence nor respect autonomy.

Second, they conclude that banning smoking in homes with children “poses no threat to adult autonomy.” From their own analysis, such a policy clearly does pose a threat to adult autonomy: namely, it removes adult autonomy over decisions about risk management for their children, themselves, and their families.

While I am not here arguing the merits or lack thereof for these home smoking bans, what I am pointing out is the bias apparent in this policy analysis. The conclusion of the piece is inconsistent with the findings of the analysis, suggesting that the authors came to a pre-determined conclusion and tried to create a post-hoc justification, rather than conducting the analysis and then basing their conclusion on the results.

While not as important as my conclusion that there is a severe bias present in the article, it is still worth noting that the piece also fails to address the fundamental question of how one can justify banning smoking in homes with children present, but not also justify policies that would regulate the foods that parents feed their children, the activities that parents allow their children to participate in, and a host of other risks to which parents expose their children. Until and unless the researchers can explain why regulating smoking is justified, but regulating these other risks is not, then they have not succeeded in providing the policy analysis that would be necessary to support the enactment of such policies.

Thursday, October 23, 2008

A new report from the Institute for Safe Medication Practices revealed that Chantix accounted for more reported serious injuries than any other prescription drug, including blackouts putting people at risk of accidents, and concluded that broader warnings are necessary to protect the public from the potential dangers of Chantix side effects.

According to the report: "Varenicline continued to provide a striking signal of safety issues that require investigation and action. In the first quarter of 2008 the FDA received 1001 case reports of serious injury in the United States in which varenicline was the principal suspect drug. For a second consecutive quarter varenicline accounted for more reported injuries than any other drug." ...

"To take further measure of the strength of the safety signal for varenicline, we made additional comparisons between varenicline and other prescription drugs. First, we explored the possibility that the market success of varenicline might partly explain the volume of serious injuries reported because millions of people had been exposed to the drug. In the first quarter of 2008, varenicline accounted for more reports of serious injury than the 10 best selling brand name prescription drugs combined. ... Varenicline accounted for 1001 cases of serious injury or death compared to 837 cases for the 10 top brand name drugs combined, and 3.5 fold more than its closest individual drug, clopidogrel, with 288 cases." ...

"ISMP’s concern about the risk of accidents was confirmed in serious adverse events reported in the first quarter data for 2008. These included 15 cases with MedDRA standardized medical terms indicating road traffic accidents. These new traffic accident cases included medical terms describing a spectrum of possible effects of varenicline that might have been responsible, such as seizure, disturbance of vision, panic attack and impaired judgment. The 2008 reports also included 52 additional cases with MedDRA terms indicating various kinds of blackouts or loss of consciousness, which have high potential for accidents. Some reported blackouts implied a sudden disruption of the heart rhythm while others appeared to be associated with psychiatric symptoms." ...

"Three U.S. government departments have addressed ISMP’s most immediate safety concern, the risk of accidents by individuals operating aircraft or vehicles and in other occupations where a lapse in alertness or motor control could lead to massive injury. The Federal Aviation Administration has banned the use of Chantix by airline pilots, the Department of Transportation has limited its use among truck drivers, and the Department of Defense has prohibited its use by aircraft and missile crews." ...

"For varenicline, additional action is needed to make all patients aware of the potential accident risks. We recommend that the FDA and the manufacturer add a prominent warning about accident risks to the patient Medication Guide and prescribing information for doctors. This warning should be similar to the new warnings about psychiatric side effects. While we commend the federal government for prompt action in banning varenicline in the most sensitive occupations such as for airline pilots, air controllers and military missile crews, a broader warning is still needed. Also, additional investigation and action may be needed regarding other adverse effects of varenicline, and prescribers should consider alternative treatments."

The Rest of the Story

The story here is not the potential adverse side effects of Chantix. Instead, the story is the potential tragedy related to the fact that national recommendations that all physicians use drug treatment for all of their patients and the recommendation of Chantix for this purpose were made by an expert panel that was chaired by a researcher with a history of severe financial conflicts of interest and that included numerous others with financial interests in pharmaceutical companies.

Drug side effects do occur and sometimes we don't know about the magnitude of these effects until after a drug is widely prescribed. What is inexcusable, however, is for national recommendations about the use of a drug to be made by individuals who have significant financial interests in companies which stand to benefit from those recommendations. This results in a severe bias in the recommendations and is unacceptable from an ethical perspective of public health policy formation.

Future expert panels which consider smoking cessation guidelines for physicians should require the recusal of all individuals with a history of significant financial conflicts of interest with pharmaceutical companies.

And in addition, the most recent expert panel which recommended the use of drugs for every smoking patient should issue an apology to the nation for allowing this substantial bias to enter its report by allowing individuals with financial conflicts of interest to take part in the development of the guidelines. The conveners of this panel should announce that researchers with significant conflicts of interest will not be allowed to participate on the panel in the future.

Judges routinely recuse themselves from making decisions in cases in which they have a conflict of interest. We should not expect anything less from public health researchers. That anti-smoking researchers with conflicts of interest did participate in decisions with national policy-setting significance is a serious ethical breach.

Wednesday, October 22, 2008

Last week, a three-judge panel of the U.S. Court of Appeals for the District of Columbia heard oral arguments in an appeal of the District Court's decision in the Department of Justice lawsuit against the tobacco companies. Both sides are appealing Judge Gladys Kessler's decision. The tobacco companies are appealing the basic decision, which found the companies guilty of violating a federal racketeering statute (RICO). The Department of Justice is appealing Kessler's decision not to allow monetary remedies, such as requiring the cigarette companies to fund a national smoking cessation program.

At the hearing, a coalition of anti-smoking groups which included Americans for Nonsmokers' Rights, the Campaign for Tobacco-Free Kids, the American Lung Association, and the American Cancer Society, argued that the panel should overturn the District Court's ruling that monetary remedies are not allowed under the civil remedies provisions of RICO.

According to a Bloomberg news article: "A group of public-health organizations, including the Tobacco-Free Kids Action Fund, the American Cancer Society and the American Lung Association, joined in the appeal to argue that Kessler should have considered stronger measures against the companies, including a program of anti-smoking education, smoking cessation programs and youth-smoking remedies. Howard Crystal, a lawyer for the health groups, argued that Kessler should have used a provision of the RICO law that permits judges to divest racketeers of assets to order an anti- smoking campaign and smoking cessation programs. `The defendants themselves consider addicted smokers to be assets,' said Crystal. 'You can't own another human being,' Judge Sentelle said."

According to a Reuters news article, Judge Sentelle admonished the anti-smoking groups for even bringing forward the argument that the panel should allow monetary remedies: "Judge Sentelle rejected a suggestion by Howard Crystal, speaking for the American Cancer Society and other public health groups, that cigarette companies should be forced to fund smoking cessation programs. Sentelle said tobacco companies could not reasonably control consumers. 'You shouldn't have brought it (to us),' he said."

The Rest of the Story

The rest of the story is that the Appeals Court has already ruled that disgorgement of tobacco industry profits is not an allowable remedy under the RICO statute. The only remedies allowable are those which are intended to directly prevent and restrain future RICO violations. In other words, the remedies must be forward-looking, not backwards-looking and intended to remedy past violations.

The anti-smoking groups appear to be plagued by a misconception of what the D.C. Court of Appeals ruled in disallowing the government's request for disgorgement of past tobacco industry profits as a remedy in this RICO-based litigation.

Somehow, the anti-smoking groups view the Appeals Court decision as only disallowing the disgorgement remedy, but not presenting any barriers to the $130 billion smoking cessation remedy.

However, what the appellate court ruled was not that somehow, the disgorgement remedy was inappropriate for some reason specific to disgorgement. Instead, it ruled that the disgorgement remedy was inconsistent with the RICO statute because that statute requires any remedy to be designed to prevent and restrain future RICO violations, not to punish or remedy past violations.

The language of the Appeals Court was quite clear: "Section 1964(a) provides jurisdiction to issue a variety of orders 'to prevent and restrain' RICO violations. This language indicates that the jurisdiction is limited to forward-looking remedies that are aimed at future violations. ... Disgorgement ... is a quintessentially backward-looking remedy focused on remedying the effects of past conduct to restore the status quo."

Without a doubt, the government's proposed $130 billion smoking cessation remedy was designed to punish the industry for, and remedy the effects of, past wrongdoing. The government had requested that the industry pay to provide smoking cessation programs to smokers who had already become victims of the industry's alleged RICO violations.

As I argued back in April 2005 (when the appellate court decision was first announced), such a program is not consistent with the appellate court's interpretation of the RICO statute because it represents a backwards-looking remedy that is measured by past wrongdoing and awarded without respect to whether future wrongdoing will take place.

Like disgorgement, the smoking cessation remedy "is measured by the amount of prior unlawful gains and is awarded without respect to whether the defendant will act unlawfully in the future. Thus it is both aimed at and measured by past conduct." These words, directly from the appellate court decision, indicate with little doubt that the $130 billion smoking cessation remedy was not allowable and will certainly not pass legal muster with the appeals court.

I have no doubt that Judge Kessler was fully aware that the "body blow" that the appeals court dealt to the DOJ case was not merely a result of the striking down of disgorgement, but the fact that it also cast doubt on the legality of the other major monetary remedies being sought by the government. That she allowed the government to go ahead with these monetary requests anyway does not indicate that she was giving final approval to such remedies, only that she thought it most prudent to at least allow the government the opportunity to present its requests. But she cautioned DOJ, in the most clear terms, that she was surprised that the government did not seem to be paying much attention to the appellate court decision.

What the rest of the story reveals is that the anti-smoking groups failed to respond appropriately in the wake of the appellate court decision by modifying their remedies requests to be consistent with the Court's interpretation of the civil remedies provisions of the RICO statute.

If anyone undermined the case, it was the anti-smoking groups, by refusing to craft an effective set of remedies that could pass appellate court scrutiny and have any decent chance of being upheld.

I think the anti-smoking groups have a lot of chutzpah going in front of this panel containing two judges who already ruled that backwards-looking remedies are not allowed and arguing that it should reverse its previous decision. You don't generally tell a group of judges that their decision was wrong. I find it extremely unlikely that the appeals court is going to declare that it was wrong and that it is going to reverse its decision.

I think the language of the RICO statute is quite clear. The decision of the District Court regarding monetary remedies will not be overturned, and it should not be overturned based on the clear language of the RICO statute.

Monday, October 20, 2008

On September 18, I reported here that the Canadian Non-Smokers' Rights Association (NRSA) had made a false accusation on its website, where it claimed that the group Citizens Against Government Encroachment (CAGE) is a Big Tobacco front group which is being secretly funded by tobacco companies. I argued that since NRSA provided no evidence to back up the accusation, it should retract the claim and apologize to CAGE.

In response to my post, CAGE notified NRSA about the false accusation. In response to CAGE's letter, NRSA examined the website and accusation in question and apparently decided that CAGE was correct and that the accusation was a false and undocumented one. NRSA has removed the accusation from the site. It has re-classified CAGE from being a front group to being an organization that behaves like a front group.

However, NRSA did not apologize to CAGE. Instead, it further attacked CAGE and insulted the group, comparing it to the "Flat Earth Society" and stating that it has no reputation worth saving. As NRSA put it: "How ... could any organization claim that its reputation was damaged when its website contains a sufficient number of passages that are so outside the boundaries of legitimate science that they ensure that the organization has no reputation worth saving? What standard of evidence would be required to substantiate an allegation that the Flat Earth Society could not be damaged by an accidental mischaracterization?"

The Rest of the Story

While I give the Non-Smokers' Rights Association credit for having removed its false accusation, I find it unfortunate that the organization, after having been caught making a false and potentially defamatory accusation, failed to apologize to CAGE. Removing the false accusation is more than NRSA's American counterpart - ANR - would likely do (based on its past behavior, which I have documented on this blog). So for that I give NRSA some credit. However, the failure to apologize to CAGE is inexcusable.

When you make a false and potentially defamatory accusation against a group publicly on your web site, I believe that you owe it to the group to apologize. It is simply the right thing to do. Any organization with scientific integrity and a respect for the truth would be expected to do so. Basic human decency also dictates that one apologize.

Instead of apologizing, NRSA has further attacked CAGE and compared the group to the Flat Earth Society. While the main point of this commentary is to criticize NRSA for its failure to offer an apology, some comment on the merit of its comparison is warranted.

If one examines the CAGE website, one hardly finds the kind of statements that are so far beyond the boundaries of legitimate science as NRSA claims. Instead, one finds a legitimate, well-argued perspective on a variety of public health issues. One may not agree with the perspective and the arguments, but they are hardly based on claims that are well beyond the boundaries of legitimate science.

For example, the CAGE site presents the perspective that in some ways, the obesity "epidemic" is being framed in the wrong way to the public, and that the obsession on weight might be counterproductive. This is a legitimate perspective and happens to be one which I present to my students in my social and behavioral sciences class because it is one which I think they need to consider. By presenting overweight and obesity as a "disease," public health practitioners are arguably adding to the stigma of excessive weight and therefore creating a self-fulfilling prophecy, rather than showing people ways to live healthier lives (ways that revolve around a healthy lifestyle, not a unitary obsession with weight).

Some public health interventions to address obesity, such as BMI report cards where elementary schools are required to send children home with report cards that "grade" children baesd on their body mass index, may actually put children at risk of developing eating disorders. Even if one does not agree with the points that CAGE is making, the perspective is a valuable one that needs to be considered.

CAGE has also presented an important perspective about conflicts of interest in science and questioned the validity of the science behind a number of scientific claims. One - which questioned the conclusion of a study which reported that kids can become addicted to smoking through exposure to secondhand smoke - was a valid criticism which I actually highlighted on my own blog.

Do I agree with everything CAGE has to say? No. But I find that the group generally provides reasonable arguments behind their opinions. And I think that taken as a whole, the web site presents some important perspectives that public health practitioners should consider.

I feel that the comparison to the Flat Earth Society is a rash and incorrect (and unfair) characterization that probably reflects either a failure to take the time to actually read the site or a knee-jerk reaction of attacking anyone who opposes one's own position (a reaction which is all too common in tobacco control).

Most importantly, I think that NRSA (and most other anti-smoking groups) fail to understand that there are groups out there which legitimately present the views of "normal" citizens who are not in any way connected with Big Tobacco or even with the hospitality industry. Not everyone who opposes tobacco control policies is a Big Tobacco front or acting like one.

And here is the critical point: As public health practitioners, we are essentially public servants. We are supposed to be serving all of the public, not just people who agree with our positions. In fact, how we deal with people who do not agree with our positions probably has a far greater impact on our effectiveness in protecting the public's health than how we deal with people who agree with our positions.

Many tobacco control groups are making the unfortunate mistake of confusing the "opposition" with the "enemy." Just because a group opposes tobacco control policies, it does not make the group an "enemy." We must learn to treat opposition groups as just that - the "opposition" to specific policies, but not as the "enemy." In fact, these groups (those which are not front groups) represent the views of members of the public, who are our clients in public health, not the enemy.

Wednesday, October 15, 2008

The 2006 Surgeon General's report on secondhand smoke concluded that chronic exposure to tobacco smoke (such as that which occurs with living with a spouse who smokes or working in a workplace that allows smoking) significantly increases the risk of lung cancer among nonsmokers. Apparently not satisfied with the urgency and appeal of this message, the CDC and the Surgeon General attempted to hype this message by convincing the public that even a brief exposure to secondhand smoke puts them at risk of lung cancer.

In the draft version of a fact sheet entitled "There is No Risk-Free Level of Exposure to Secondhand Smoke" (see final version here), the CDC and Surgeon General included the following "fact":

"Inhaling even a small amount of secondhand smoke can damage your cells and set the cancer process in motion."

The clear implication of "setting the cancer process in motion" is "causing you to get cancer." People are going to naturally interpret this statement as implying that since the cancer process has been set in motion, it is going to inevitably lead to cancer. In other words, the statement is going to be interpreted (rightly so) as an assertion that even a very brief exposure to secondhand smoke can cause lung cancer.

I am aware of no actual scientific evidence that this assertion is true. Moreover, I think it is very deceptive to try to convince people that they have a substantial risk of developing lung cancer if they are exposed to secondhand smoke even briefly.

This is problematic not only because it is deceptive, but because it unnecessarily scares people and it undermines the message that people need to take away: that they should try to minimize their exposure to secondhand smoke. By trying to convince people that even a brief exposure sets the cancer process in motion, the Surgeon General and CDC are essentially telling people not to make any effort to limit their exposure, because it's too late - they are already on the road to lung cancer. If a brief exposure has already started the cancer process, then why bother to protect yourself from tobacco smoke in the future? It's too late: the cancer process has already started.

This type of hysteria is not only a distortion of the science, but a deception of the public. It is not only an exaggeration of the science, it is a disservice to the public.

If the Surgeon General and CDC are going to tell the public that even a brief exposure to secondhand smoke sets the cancer process in motion, then it is also true that even a brief exposure to sunlight sets the cancer process in motion. So does getting a chest X-ray. But no public health official in his or her right mind would start warning the public that getting a single chest X-ray or being in the sun for one minute will set the cancer process in motion.

Can you imagine if CDC or the Surgeon General used the same hype with some of these other exposures? Suppose that they put out a press release stating that "Inhaling even a tiny amount of radon for five minutes can set the cancer process in motion." It would be very clear that they were being irresponsible and that they were trying to hype the message and deceive the public into a state of unnecessary panic.

Apparently, the actual conclusions of a comprehensive 727-page report which documents all kinds of adverse health effects of secondhand smoke were not sensational enough for the Surgeon General's office and for CDC. In what seems to be a contagious phenomenon which has now infiltrated a federal tobacco control organization, public health groups that report the science of secondhand smoke do not seem able to accurately report the science to the public.

Rather than sticking to the carefully-reviewed science in the detailed and thorough report, the press release and other related communications of the Surgeon General regarding the findings of his report were sensationalized in a way that makes these communications quite misleading.

The report documents an increased risk of heart disease and lung cancer among nonsmokers who are chronically exposed to high levels of secondhand smoke. However, instead of simply reporting that finding to the public, the Surgeon General and CDC distorted the science to communicate to the public that brief exposure to secondhand smoke can increase heart disease and cancer risk.

I need to make it clear that none of these misleading and inaccurate scientific claims are made in the Surgeon General's report itself. What appears to be going on here is very similar to the "20-minute" and "30-minute" claims about which I have written extensively: the science is simply being distorted to sensationalize the findings, resulting in assertions that are misleading, inaccurate, absurd, unsupported by scientific evidence, and inconsistent with the findings of the report itself.

It appears to me that tobacco control organizations of all kinds and at every level are simply unable to accurately and honestly communicate the science of secondhand smoke to the public. For some reason, there appears to be a need to distort the science in an effort to sensationalize it and increase the emotional impact of the communication. The end result is to produce public claims that are inaccurate and which mislead the public.

It is important to understand that while the Surgeon General's report itself underwent rigorous scientific review, and thus does not make any outlandish claims, the communications put out by the Surgeon General reporting the findings of the report did not undergo independent scientific review. And it really shows. The difference between the press release and related communications and the Surgeon General's report itself are striking.

What has gone wrong?

I worked for two years at the Centers for Disease Control and Prevention, in the Office on Smoking and Health, which is the office that usually leads the review of the Surgeon General's report. So I'm quite familiar with the level of scrutiny that is usually applied to any communications by the Surgeon General, but especially with regards to what is viewed as the rather "controversial" issue of secondhand smoke.

We remained highly vigilant and very careful about our public communications about the effects of tobacco smoke and those of the Department of Health and Human Services, because there was a huge perceived tobacco industry presence that would scrutinize our claims and call us to task if there were any inaccuracies, even if they were slight and not particularly meaningful.

But now, with the tobacco companies having largely abandoned this "oversight" role and playing a back-seat role (their main comment on the report was something to the effect of "We haven't fully reviewed it yet"), there is apparently nothing to stop us from making just about any claims that we want to make.

So if we want to impress the public with the magnitude of the secondhand smoke hazard by trying to convince them that even a brief exposure can cause heart disease and lung cancer, so be it. The tobacco industry is not going to get in our way any more. Why should the science?

NOTE: Since a large number of readers of this particular post are likely not to be regular readers of this blog, I want to make it clear that I agree with most of the conclusions of the Surgeon General's report itself and that I certainly (and have for many years) believed that chronic secondhand smoke exposure is a cause of heart disease and lung cancer. I believe that the conclusions of the Surgeon General's report are sufficient to justify smoke-free workplace laws. But I think that the truth is enough. I don't see why we need to distort and sensationalize the science in order to increase the impact of these findings and attempt to advance the agenda. In my view, it greatly harms public health by threatening the very credibility of tobacco control and public health practitioners and organizations. In the long run, this is going to harm the public health cause more than any fleeting publicity gains to be obtained from trying to convince people that breathing drifting tobacco smoke for a half hour is going to cause you to have a heart attack, develop atherosclerosis, or come down with lung cancer 30 years later.

The only relevant section of the text of the press release states: "Even short-term exposures -- lasting as little as 30 minutes -- may pose significant risks, especially in persons who already have or are at special risk of heart disease."

The Rest of the Story

The claim made in the headline of the press release is not qualified. That is, it clearly suggests that short-term secondhand smoke exposure may trigger heart attacks in anyone, not just someone who has severe, pre-existing coronary artery stenosis. Thus, the headline suggests to the media that a short exposure to secondhand smoke is sufficient to cause a heart attack in a healthy individual.

In the text of the press release - the only place where the headline's claim is discussed - it states that as little as 30 minutes of exposure poses significant risks, especially in persons with pre-existing heart disease. The inclusion of the word "especially" implies that the significant risks being discussed also apply to healthy individuals.

Thus, taking the press release as a whole, it seems to be suggesting that a mere 30 minutes of secondhand smoke exposure is enough to cause a heart attack in a healthy individual.

This is impossible. A healthy individual cannot suddenly develop heart disease in 30 minutes. To someone without severe heart disease, a 30-minute exposure is not going to trigger a heart attack. So the press release is very misleading.

The rest of the story, then, is that the 30-minute heart attack claim appears to have come, at least in part, from the CDC and its 2004 press release, which suggested to the media that brief secondhand smoke exposure can trigger a heart attack in a healthy individual.

It appears that this press release was what resulted in the widespread media misrepresentation of the science to the public. Headlines throughout the country warned the public that if they are exposed to secondhand smoke even briefly they could drop dead from a heart attack. Most of the coverage of the CDC's statement did not qualify the claim, clearly implying to the public that 30 minutes of secondhand smoke exposure can cause a heart attack in even a healthy individual without pre-existing heart disease (or with very mild heart disease).

For example, this article from CNN stated: "According to the CDC, exposure to secondhand smoke for as little as 30 minutes can significantly increase your risk of heart attack." Note that the article stated: "increase your risk," not "increase the risk for someone with severe, pre-existing heart disease."

The difference between these is huge. In fact, it is the difference between true and false. It is the difference between accurately communicating science to the public and wildly misleading the public with exaggerated, unsupported scientific claims.

Unfortunately, it may also be the difference between having a public that trusts public health officials and one which discounts what it hears because it is used to receiving exaggerated and distorted information.

Monday, October 13, 2008

Their Decision:Do Not Engage in Scientific Discussion; Keep It Ad Hominem or Simply Ignore Him

The Centers for Disease Control and Prevention (CDC), the Campaign for Tobacco-Free Kids (TFK), and the Senior Scientific Editor of the Surgeon General's report on secondhand smoke had a discussion about how to handle my criticism of the Surgeon General's press release, which misrepresented the science on the acute cardiovascular effects of secondhand smoke.

This discussion was in response to my blog post which argued that the press release issued by the Surgeon General's office was misleading because it claimed that: "Even brief exposure to secondhand smoke has immediate adverse effects on the cardiovascular system and increases risk for heart disease and lung cancer, the report says."

The discussion also continued in response to my being quoted in a JAMAarticle about the Surgeon General's misrepresentation of the science in his press statements.

The Surgeon General's assertion is that brief exposure to secondhand smoke increases risk for heart disease and lung cancer, and that his report drew such a conclusion. The falsehood of the second part of that assertion is easily proven, since nowhere in the report does it conclude that brief exposure to secondhand smoke increases the risk of heart disease or lung cancer.

The falsehood of the first part of the assertion is also easily shown, since it takes many years of secondhand exposure to develop heart disease. A single, brief exposure cannot possibly cause heart disease. A person who is exposed briefly to secondhand smoke is not at an increased risk for heart disease due to that single exposure.

It's like saying that drinking a glass of whole milk increases your risk for heart disease. A single glass of whole milk may well cause endothelial dysfunction and platelet activation, as does any high-fat bolus. But the CDC would not warn the public that drinking a glass of whole milk increases the risk of heart disease. If you drank whole milk repeatedly and for many years, then it could contribute to an increased risk of heart disease. But not a single drink.

As far as brief exposure to secondhand smoke increasing the risk for lung cancer, there is simply no evidence that this is the case. The CDC could fall back on the notion that there is no threshold for cancer effects. But that reasoning would mean that the CDC should also be warning that eating any amount of peanut butter increases the risk of cancer (since it contains aflatoxin, a potent carcinogen). Clearly, one cannot assert that any exposure to something which contains a carcinogen is going to increase your risk of cancer. There needs to be evidence to back up such a claim.

This is the context of my criticism of the Surgeon General's press release. Note, also, that I was not criticizing the report itself. In fact, I used the report as evidence to support my contention that the Surgeon General's press remarks were misleading.

The discussion was initiated by the Campaign for Tobacco-Free Kids, which wrote a letter to the scientific editor of the Surgeon General's report, asking him to draft a response to my criticism: "I'm writing to explore your willingness to draft a response to some recent op-eds and blog entries by Dr. Michael Siegel from Boston University related to the recent SGR on exposure to secondhand smoke. As you may be aware, Dr. Siegel has become something of a resident contrarian on a variety of issues related to tobacco control, and one that he has focused on lately is the issue of short-term exposure to secondhand smoke and his contention/claim that the SG has misrepresented the science in general and specifically misrepresented the science within the SG report itself. While Dr. Siegel's postings on various tobacco control listservs may prove troublesome or irksome to some, they do not do any harm. But he now has begun to insert himself into local smokefree battles around the country and, whether he realizes/intends it or not, is providing ample fodder to the opposition and media calling into question the validity of the underlying science - even though he caveats his statements with saying he favors restrictions, etc...but he then proceeds to raise questions calling into question the science. ..."

"We were hoping that you, as the senior scientific editor of the SGR, might be willing to craft a response to Dr. Siegel that we could work with you in getting placed in various publications where Dr. Siegel has been appearing - the most recent being the St. Paul Pioneer Press in Minneapolis/St. Paul, Minnesota. ... While we would normally choose to ignore Dr. Siegel and not give him any more credence/attention than he deserves, we think his actions in taking his arguments to a broader, more public stage warrant a response."

In response, the senior scientific editor of the Surgeon General's report wrote: "...my first thought is to ignore Siegel and not 'dignify' his points of criticism with a response - I suspect that he will become silent if ignored, but if he persists or becomes more vocal, then let's discuss."

Tobacco-Free Kids responded: "That has been our general approach with Siegel and it has been mostly successful. What is different this time is he is not containing his 'opinions' to just his blog or various listservs but is doing it in a much more public forum via newspaper op-eds, he's been interviewed on TV, etc...".

The CDC responded: "I don't think anything we say is going to stop Mike, given the fact that the SG has said it, and that hasn't stopped him. Engaging just gives him an excuse to write another editorial, commentary, or blog."

In a separate note, CDC wrote: "It does not seem to be productive to engage Mike - he is not interested in discussing the science."

After the JAMA article appeared, the senior scientific editor of the Surgeon General's report wrote: "...a very disappointing story from JAMA--I am tempted to write to Cathy DeAngelis--what does not come across is the process of development of the SG reports, including the rigorous development and peer review--and offering a forum to Siegel who does not have the credentials to scientifically support what he is saying...".

The Rest of the Story

What is most fascinating about reading these exchanges is the trepidation of these groups to actually become engaged in a discussion of the science behind the Surgeon General's claim. Moreover, the discussion is not focused on whether my criticism has merit, but instead is focused on how to discredit me.

When it finally came down to it, the senior scientific editor of the Surgeon General's report made no comment about the scientific justification for the press release statement; instead, he resorted to an ad hominem attack on me, challenging my credentials to express my opinion. Interestingly, there was never any concern about my credentials in writing and reviewing numerous sections in prior Surgeon General's reports. I guess my credentials suddenly disappeared when I opined in a way that was unfavorable to the extremist claims of the movement.

The CDC comments are most interesting because they were written by a close colleague of mine from the Office on Smoking and Health, someone who I worked closely with for two years and who is very familiar with my scientific expertise in the area of tobacco control science. Those comments are also ironic, because I am very happy to be engaged in a discussion of the science. It is these groups which have refused to engage in such a discussion.

It is really instructive for me to see how these groups treat a former colleague who worked closely with them in formulating all kinds of scientific documents about the health effects of secondhand smoke. The way that these groups are treating me, I might as well have gotten a job working for the tobacco industry. You would never know that I am a colleague who worked in the same office at CDC and contributed to Surgeon General's reports.

It is clear that having an opinion that is viewed as being on "the other side" is fatal to your career in tobacco control. There simply is no room for dissent on the science. You automatically become an enemy, a member of the opposition, someone to be ignored or even worse - discredited. It is very much like a religion.

Thursday, October 09, 2008

Despite a warning from a prominent tobacco control researcher, the Centers for Disease Control and Prevention used the evidence from the Helena study to widely disseminate to the public unsupported conclusions about the immediate effects of restaurant and bar smoking bans on heart attack rates.

Writing to the Centers for Disease Control and Prevention (CDC) about a draft of its commentary that accompanied the Helena study, this prominent tobacco control scientist wrote:

"I would be very cautious with this and I think the first couple of paragraphs are far too strong for the data presented in the paper. I have seen earlier drafts of this paper with more complete descriptions of the data that were far less compelling. In your discussion of the limitations you seem to believe that the numbers presented are per month. That is not true, they are for the 6 month interval (i.e., 3-4 cases per month), and the difference is largely in the first couple of months in the earlier drafts. Small numbers or no, it would be useful to know the distribution of current, former, and never smokers for the different years (would you feel differently if 70% of the 24 AMI [acute myocardial infarctions] in Helena during 2002 were current smokers for example). The reluctance to produce these breakouts is concerning.

To validate this article with a CDC editorial ("the answer is yes") runs the risk of the writers of the editorial being associated with the over interpretation of the data presented in the article and you should think carefully about it. At best this is a provocative observation, but to suggest that it demonstrates that smoke free ordinances can lower AMI rates is wishful thinking."

While the exact identity of the scientist who wrote this commentary is not known, I have narrowed it down to four possible individuals, each of whom is a highly-respected tobacco control researcher from within the anti-smoking movement. Each of these individuals has served as a frequent editor and reviewer of the Surgeon General's reports on smoking and health.

The Rest of the Story

The rest of the story is this: why is the opinion of this researcher, who clearly represents a substantial contingent within the anti-smoking movement, hidden upon secret documents that were only able to be obtained through a Freedom of Information Act request?

Why did this researcher, and others like him, who disagreed with the conclusions of the Helena study and the use of this study to argue that smoking bans immediately and dramatically reduce heart attacks, fail to make their concerns known more widely than just in this email?

If there are many others out there in the movement, who like me, believe that the Helena science is shoddy and that the findings have been over-inflated, then why have I been the only one willing to speak out?

And if my opinions are actually quite solid, as they appear to be from this highly respected researcher's commentary, then why have I been attacked viciously and consistently by the anti-smoking movement and accused of being an outsider and a traitor?

The answer is quite simple: because I went public with my comments. You aren't allowed to do that in tobacco control. If you dissent, you are allowed to write polite, personal, and private emails expressing your opinion, but you are not allowed to go public with your dissenting comments. You have to shut up and keep your opinion to yourself.

That is what many scientists in tobacco control did. And for good reason. If you go public, they will ruin your career. They will do everything they can to discredit you. You will be evicted from the movement. You will be accused of being a tobacco mole and a traitor.

What I want people to take away from this story, and the reason I think it is so vitally important, is that it demonstrates conclusively that my opinions regarding the shoddiness of the Helena study and the over-inflated conclusions from this study are shared by many other respected scientists within tobacco control. Many of my colleagues share precisely my views with regards to this area of research.

However, you will not find these views expressed publicly in any forum. To do so would be fatal to these researchers' careers in tobacco control.

Thus, the only views you will see from someone within the movement are my own. And the fact that I went public with these comments is what got me ex-communicated from the movement.

It is really a McCarthyist-like movement. You cannot express dissent publicly. You must tow the party line. You are allowed to disagree - privately. You are allowed to express your disagreement - privately. But you can't talk about it. You have to keep it to yourself. If you go public, that's it - you're ostracized, attacked, victimized. Thrown off the list-serves. Not allowed to present at conferences. Defamed behind your back.

The sad thing is that I was thrown out of the movement for expressing exactly the views expressed by this prominent, respected tobacco control researcher. He, like everyone else in tobacco control, knows that if he were to express these views publicly, he would be in the same boat as I am: sent away from the main ship to exile on a desert island. That's why it takes a Freedom of Information Act request to uncover these views of scientists from within the movement.

To interfere in any way with the movement's ability to promote smoke-free laws based on the most wild and exaggerated (and unsupported) claims is fatal to anyone's existence within the movement.

That more recent population-based studies do not support the Helena conclusion is of no consequence in this movement. Not because this evidence doesn't convince numerous scientists within the movement that the conclusions from Helena are wrong. But because there can be no public statement that anyone disagrees. The researchers have to keep it to themselves. They can discuss it amongst themselves, privately, in emails and at conferences. But they are not allowed to express it publicly. There can be no public debates about the established wisdom in tobacco control.

In a previous post, I commented on the express preemption argument in the Altria v. Good case that is now before the Supreme Court. The oral arguments focused on this aspect of the case as well. In this post, I comment on the implied preemption aspect of the case.

I believe that Philip Morris is correct when it argues that state-law damage claims based on fraudulent advertising of "light" or "low-tar" cigarettes are impliedly preempted because the Federal Trade Commission has specifically authorized the use of these descriptors if used in a certain way.

There were two consent orders in which the FTC specifically permitted certain "low-tar" and "light" claims and set out conditions under which these claims could be made.

One of these was American Tobacco Co., FTC Docket No. C-3547 in 1994. According to the Illinois Supreme Court's description of this consent order: "The agreed order provided, further, that 'presentation of the tar and/or nicotine ratings of any of respondent’s brands of cigarettes and the tar and/or nicotine ratings of any other brand (with or without an express or implied representation that respondent’s brand is ‘low,’ ‘lower,’ or ‘lowest’ in tar and/or nicotine) shall not be deemed' to violate the ban on numerical comparisons. American Tobacco, 119 F.T.C. at 11."

Another relevant consent order was issued in 1971 and involved a complaint against American Brands for implying in its advertising that certain cigarettes were low-tar: "The dispute between the FTC and American Brands was resolved in 1971, with the entry of a consent order that required American Brands to cease and desist from: Stating in advertising that any cigarette manufactured by it, or the smoke therefrom is low or lower in ‘tar’ by use of the words ‘low,’ ‘lower,’ or ‘reduced’ or like qualifying terms, unless the statement is accompanied by a clear and conspicuous disclosure of: 1. The ‘tar’ and nicotine content in milligrams of the smoke produced by the advertised cigarette; and 2. If the ‘tar’ content of the advertised brand is compared to that of another brand or brands of cigarette, (a) the ‘tar’ and nicotine content in milligrams of the smoke produced by that brand or those brands of cigarette, and (b) the ‘tar’ and nicotine content in milligrams of the lowest yield domestic cigarette.” American Brands, 79 F.T.C. at 225."

The Illinois Supreme Court concluded that: "the FTC could, and did, specifically authorize all United States tobacco companies to utilize the words “low,” “lower,” “reduced” or like qualifying terms, such as “light,” so long as the descriptive terms are accompanied by a clear and conspicuous disclosure of the “tar” and nicotine content in milligrams of the smoke produced by the advertised cigarette."

The Rest of the Story

Since the Maine smokers are asking for damages suffered due to the current, or recent advertising of Philip Morris cigarettes, I do not believe that such claims are allowable because they relate to a time period during which the Federal Trade Commission has specifically authorized the use of these descriptors and spelled out the conditions under which these descriptors can be used.

A consent order, while it may only affect a particular company, does provide guidance to the overall industry and thus can be interpreted as an authorization of company behavior in that area.

One important lesson here is the degree to which the federal government bears some responsibility in the deception of smokers about the safety of using low-tar and light cigarettes. The Federal Trade Commission, which has assumed jurisdiction over the tar and nicotine content of cigarettes and the advertising of cigarettes with regard to this content, has failed in its regulatory efforts.

The deception of smokers is not just in the hands of the cigarette companies. It is also in the hands of the federal government, for assuming jurisdiction over, but failing miserably to address the advertising of tar and nicotine levels to smokers. In fact, the federal government has knowingly misled smokers for years by requiring labeling that is inherently deceptive. The cigarette companies have been required by law to provide these deceptive figures.

While one can certainly place blame on the cigarette companies prior to the time when the facts about compensation (the process by which smokers inhale differently to obtain the same amount of nicotine in a low-yield product) were widely known by the government, one can no longer view things in the same way. The federal government - specifically, the FTC - now bears that responsibility. It is only in the last few months that the FTC has finally questioned its own decision to mandate the tar and nicotine ratings, as it has recently asked for public comment about disbanding or altering this long-standing system.

Interestingly, the federal government's complicity stems not so much from its failure to assert jurisdiction over tobacco products, but from its having asserted jurisdiction over aspects of tobacco in a weak and ineffective way, but in a way that ended up preempting meaningful state and local regulation as well as providing a large measure of immunity to the tobacco companies.

We would be far better off, I believe, if the government had simply stayed out of the regulation of tobacco completely.

I opined earlier this week that the Court will issue a close decision (probably 5-4) with regards to the express preemption aspect of the case. While I originally declined to actually make a definitive prediction, upon further thought I believe that at least one justice (beyond the 4 who will clearly interpret FCLAA's preemption clause as being sweeping) will be swayed by Philip Morris' argument that the Cipollone plurality (seven justices ruled that fraudulent advertising claims are not preempted by FCLAA) is not applicable to the Good case because the intent in Cipollone was to allow claims regarding the material misrepresentation of facts, not misleading or depeptive advertising claims.

Given the extensive FTC history on this issue and the fact that the tobacco companies are, to some extent, making a factual representation (albeit misleading) in using the term "light" to refer to cigarettes with lower yields on the FTC test, I believe that at least one of the required justices will find that while FCLAA's preemption does allow for fraudulent advertising claims, the specific claim being made in this case is not allowed because it does not involve the material misrepresentation of factual information.

Thus, I am amending my prediction to call for a 5-4 victory for Philip Morris on the express preemption argument (the "swing" justice[s] will concur in part, and dissent in part - concur on the disallowance of the claim in this case, but not agree that all fraudulent advertising claims are disallowed).

I believe that the implied preemption argument is even stronger, because it doesn't present the uncomfortable position of a justice having to concede that a consumer cannot make any claim against tobacco companies for deceptive advertising, no matter how patently false the advertising may be. With the implied preemption claim, the argument is simply that the FTC has specifically authorized the use of the "lights" and "low-tar" descriptor.

Therefore, I expect a 6-3 victory for Philip Morris on the implied preemption argument.

Wednesday, October 08, 2008

Today I offer a puzzle for Rest of the Story readers. Below is a commentary (unpublished) written by a scientist regarding the famous Helena study. The Helena study concluded that the smoking ban in that city immediately and dramatically reduced heart attack admissions (by 40%). That study has been widely cited throughout the world as demonstrating that smoking bans quickly and dramatically reduce heart attack rates.

The question is this: who wrote this commentary?

Writing to the Centers for Disease Control and Prevention (CDC) about a draft of its commentary that accompanied the Helena study, the scientist in question wrote:

"I would be very cautious with this and I think the first couple of paragraphs are far too strong for the data presented in the paper. I have seen earlier drafts of this paper with more complete descriptions of the data that were far less compelling. In your discussion of the limitations you seem to believe that the numbers presented are per month. That is not true, they are for the 6 month interval (i.e., 3-4 cases per month), and the difference is largely in the first couple of months in the earlier drafts. Small numbers or no, it would be useful to know the distribution of current, former, and never smokers for the different years (would you feel differently if 70% of the 24 AMI [acute myocardial infarctions] in Helena during 2002 were current smokers for example). The reluctance to produce these breakouts is concerning.

To validate this article with a CDC editorial ("the answer is yes") runs the risk of the writers of the editorial being associated with the over interpretation of the data presented in the article and you should think carefully about it. At best this is a provocative observation, but to suggest that it demonstrates that smoke free ordinances can lower AMI rates is wishful thinking."

The Rest of the Story

It was very interesting for me to read this commentary on the Helena study and its accompanying editorial, because it expresses exactly my scientific opinion regarding that study. At very best, the results of the Helena study are provocative. But the sample size is so small that the study cannot possibly conclude that the observed change in heart attacks is attributable to the smoking ban. To suggest that the Helena study demonstrates that smoke free ordinances can lower acute myocardial infarction rates is wishful thinking.

In addition, the commentary is interesting because it warns the CDC scientists not to put their own scientific integrity into question by blindly jumping on the Helena bandwagon. To argue that the Helena study supports the conclusion that smoke-free ordinances immediately decrease heart attacks or that the study demonstrates the positive benefits of a smoke-free ordinance would amount to over-interpretation of the data presented in the article.

While the CDC did tone down the article and included some limitations of the Helena study, it unfortunately did not alter its underlying conclusion that brief secondhand smoke exposure precipitates heart attacks among nonsmokers, and the headlines derived from the CDC commentary were wildly exaggerated and misleading.

Who do you think wrote this commentary, which expresses a scientific opinion which is virtually identical to that which I have expressed for many months on this blog?

Tuesday, October 07, 2008

The United States Supreme Court yesterday heard oral arguments in the case of Altria v. Good, an appeal of a Maine lawsuit which will likely determine the fate of all "lights" cigarettes suits in the nation.

In the original case, four Maine smokers allege that they were defrauded by Philip Morris advertising for "light" cigarettes, which turns out to be deceptive advertising because so-called "light" cigarettes expose smokers to virtually the same level of nicotine and tar as "regular" cigarettes.

Philip Morris argues that the claim is barred by an express preemption clause in the Federal Cigarette Labeling and Advertising Act of 1965, as amended in 1970, which established mandatory warning labels for cigarette packages and advertisements and placed regulatory authority over cigarette advertising into the hands of the Federal Trade Commission.

The relevant clause states: "No requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provisions of this chapter." [see U.S.C. 15, 1334(b)]

The attorney for the smokers argues that the federal preemption clause does not apply to claims brought solely on the basis of fraudulent advertising, rather than on smoking and health. And he argued, further, that the Maine smokers' claim had nothing to do with smoking and health, just fraudulent advertising.

Moreover, the plaintiffs' attorney argues that in Cipollone v. Liggett, the Supreme Court (7 of 9 justices) ruled that fraud cases are not preempted by the Federal Cigarette Labeling and Advertising Act.

In opening arguments, the plaintiffs' attorney struggled to try to convince the Court that the Maine smokers' claim has nothing to do with smoking and health and that it is merely a deceptive advertising claim. Justice Scalia gave him a hard time with this argument but notably, was joined by Justices Souter and Kennedy, who seemed nonplussed with the argument that the claims are not preempted because they don't at all relate to smoking and health. Justice Kennedy in fact gave the plaintiffs' attorney a chance to apply a second line of reasoning.

The Rest of the Story

In my opinion, Justice Ruth Bader Ginsburg is going to decide this one, breaking a 4-4 tie among the other justices.

I was never one of those athletes who would "guarantee a victory" and I'm not a tobacco legal analyst who usually pretends to be able to predict how a court is going to rule, but I think it's pretty clear how 8 of the 9 justices are going to rule on this case.

First of all, in Cipollone v. Liggett Group, Inc. [see 112 S.Ct. 2608, 505 U.S. 504, 120 L.Ed.2d 407], Justices Scalia and Thomas have already argued that section 4 of FCLAA preempts all state-law damages actions based on claims of fraudulent advertising. They will most likely reiterate this opinion and be joined by Justices Alito and Thomas.

Scalia and Thomas argued in Cipollone that: "I would apply to all petitioner's claims what I have called a 'proximate application' methodology for determining whether they invoke duties 'based on smoking and heath' - I would ask, that is, whether, whatever the source of the duty, it imposes an obligation in this case because of the effect of smoking upon health. On that basis, I would find petitioner's failure-to-warn and misrepresentation claims both pre-empted."

In Altria v. Good, this 'proximate application' methodology would certainly yield a conclusion that the "lights" damages claims are preempted. The very reason why the "lights" advertising is relevant is because of its implications for smoking and health. The advertising is deceptive specifically because it implies a degree of safety from these cigarettes when this degree of safety is not present. The smoking and health link is the lynchpin which imposes the duty on cigarette companies not to represent low-tar or low-nicotine cigarettes as "lighter" than others.

Second of all, in Cipollone, Justices Stevens, Kennedy, and Souter ruled that while FCLAA does preempt some state-law damages actions, it does not specifically preempt claims based on intentional fraud in advertising by false representation and hiding of material facts. They will most likely reiterate this opinion and be joined by Justice Breyer.

Justices Stevens, Kennedy, and Souter wrote in Cipollone that: "State-law prohibitions on false statements of material fact do not create 'diverse, nonuniform, and confusing' standards. Unlike state-law obligations concerning the warning necessary to render a product 'reasonably safe,' state-law proscriptions on intentional fraud rely only on a single, uniform standard: falsity. Thus, we conclude that the phrase "based on smoking and health" fairly but narrowly construed does not encompass the more general duty not to make fraudulent statements. Accordingly, petitioner's claim based on allegedly fraudulent statements made in respondents' advertisements is not pre-empted by section 5(b) of the 1969 Act."

I don't see anything in this case that is likely to change the minds of these justices or to somehow apply their earlier reasoning in a different way.

Thus, we are likely to have a 4-4 tie, which would be broken by Justice Ginsburg, who joined the Court shortly after the Cipollone decision.

And, no, I'm not going to predict how she will rule. I have no idea.

Were I to decide the case, I would rule in favor of Philip Morris. First, I think it is unquestionable that the claim being brought by the Maine smokers is based on an advertising prohibition or requirement that is based on smoking and health. The issue of whether calling a cigarette "light" is fraudulent depends specifically on whether or not it delivers the same amount of harmful ingredients as a "regular" cigarette. The issue is relevant only because of the implied safety of the cigarette. Without the implication of a safer cigarette, there are no damages to the smokers. There is no question that the subject matter of the preemption clause applies to the content of the damages claim.

Second, as Philip Morris pointed out in its petitioner's brief: "Where, as here, a statute contains an express pre-emption clause, the task of statutory construction must in the first instance focus on the plain wording of the clause.” CSX Transp., Inc. v. Easterwood, 507 U.S. 658, 664 (1993).

The plain wording of the preemption clause is quite clear. Any claims with respect to requirements for cigarette advertising that are based on smoking and health are preempted. One could almost read that wording with the Good case in mind. Can there be a better example of an advertising requirement based on smoking and health?

I think the intent of Congress in enacting FCLAA was quite clear. Its primary purpose was to occupy the field of regulation of cigarette advertising. The only reason the legislation passed was that it had the quiet blessing of the tobacco companies, which were content with having to put the warning labels in place as long as they received something more valuable to offset that sacrifice: namely, immunity from lawsuits based on a failure to warn or deception in advertising. I don't think there was any question when the legislation was enacted that this was exactly the intent: occupy the field of cigarette advertising to the exclusion of any state action on this issue.

While I understand why Justices Kennedy, Souter, and Stevens are uncomfortable with the idea of Congress intending to preclude any state regulation of cigarette advertising based on smoking and health, no matter how deceptive, I have no doubt that is exactly what Congress intended.

Monday, October 06, 2008

A new study published online ahead of print in the journal Addictive Behaviors has concluded that secondhand smoke exposure, especially in a car, may cause nicotine dependence among children who have never themselves smoked (see: Belanger M, et al. Nicotine dependence symptoms among young never-smokers exposed to secondhand smoke. Addictive Behaviors 2008, doi:10.1016/j.addbeh.2008.07.011).

The study examined symptoms of nicotine dependence among a cross-sectional sample of 1,488 never smokers, ages 10-12 years, in a stratified sample of schools in Montreal. Using multiple logistic regression and controlling for smoking among friends and siblings, the paper finds an increased odds of self-reported nicotine dependence symptoms among children with higher levels of secondhand smoke exposure in automobiles.

The authors conclude that secondhand smoke exposure - and in particular, exposure to tobacco smoke in cars - may cause nicotine dependence in young neversmokers: "Overall, these data suggest an interesting and potentially important hypothesis -- that exposure to secondhand smoke may potentiate nicotine dependence symptoms in young never-smokers. ... If replicated, these findings support public health interventions that promote non-smoking in the presence of children, and more specifically uphold policy interventions to restrict non-smoking in motor vehicles in which children are present."

The results of the study have been widely reported in the media as showing that secondhand smoke exposure can cause nicotine dependence among nonsmoking children. For example, the headline about this study in the Calgary Herald read: "Smoking Parents Can Hook Kids on Nicotine."

Other news headlines about the article include:

Second-Hand Smoking Can Lead to Nicotine Addiction in Children (InjuryBoard.com)

When I went to read the actual study, I was expecting research that measured symptoms of nicotine withdrawal in children, such as cravings for nicotine that are initiated when one is in the absence of nicotine but relieved by nicotine or symptoms of nicotine withdrawal that occur when nicotine exposure is ended, such as irritability, inability to concentrate, insomnia, fatigue, or headache.

To my surprise, the study did not actually measure nicotine dependence among young neversmokers. Instead, what the study used was a nicotine dependence assessment tool that was designed specifically for smokers. The measurement tool that was used was not relevant to measuring nicotine dependence symptoms in nonsmokers. In fact, nearly all the questions assumed that the respondent was a smoker and these questions were therefore irrelevant and not applicable to these nonsmoking respondents. Any nonsmoking youth would have had considerable difficulty answering these questions which clearly did not apply to them.

For example, one question was: "Do you find it difficult not to smoke in places where it is not allowed (at a movie theatre, at home if your parents don't know you smoke)?"

What in the world does this mean for a person who is a nonsmoker? Clearly, the question is designed for smokers and it has no place in the assessment of nicotine dependence among neversmokers.

The other questions, while arguably not as strictly irrelevant, were still inappropriate for the assessment of addiction among a nonsmoker. In fact, the questions, if anything, were leading questions that could easily lead a nonsmoker to report feeling addicted to cigarettes or to answering in a way that indicated addiction, even in the absence of any actual addiction.

Both of these are leading questions which suggest to the respondent that it is not only possible for them to be addicted but that it is expected that they might be addicted.

The other questions were:

"How often do you have cravings to smoke cigarettes?"

"How often have you felt like you really need a cigarette?"

"When you see other kids your age smoking cigarettes, how easy is it for you not to smoke?" and

"[Do you] sometimes have strong cravings for cigarettes where it feels like [you are] in the grip of a force that [you] cannot control?"

Answering "yes" or "sometimes" to any one of these questions yes puts you into the addicted category for the analysis upon which the authors based their conclusions.

Quite clearly, in the context of nonsmokers, what these questions measure is not physical dependence upon nicotine, but the propensity to start smoking. In other words, for a nonsmoker, these questions are a measure of that individual's closeness to starting to smoke. What these questions really ask is not "Are you nicotine dependent?", but instead "How much of an urge are you experiencing to experiment with cigarettes?"

Now, here's the rub:

One would expect that exposure to secondhand smoke (i.e., living with one or more smokers, having a smoking parent, being in a car with a smoker [which likely means having a parent who smokes]) would be highly correlated with the urge to experiment with cigarettes. Thus, the study was set up in such a way to find that secondhand smoke exposure is associated with nicotine dependence.

What the study is actually finding is that the degree of secondhand exposure is associated with the extent of an individual's urge to experiment with cigarettes. This is quite plausible, since higher secondhand exposure usually indicates a higher number of parents/siblings/friends who smoke and/or a heavier intensity of smoking and higher level of dependence on smoking among family members or close friends. Such a finding is not at all a surprise, and does not really add anything new to the smoking literature.

However, this study concludes - instead - that the results indicate that the degree of secondhand smoke exposure is related to the extent of nicotine dependence. This alternative hypothesis is clearly a wild one and is unsupported by the data, which do not actually measure nicotine dependence among nonsmokers.

Before one could purport to have found a relationship between secondhand smoke and nicotine dependence among 10-12 year-old nonsmokers, one would have to validate a measurement instrument to assess nicotine dependence among nonsmokers. The study fails to do that. In fact, it borrows, without adaptation, an instrument that was specifically designed to assess nicotine dependence among adolescents who smoke.

The conclusions of the study and the worldwide headlines are way overblown. In fact, overblown isn't really right because that suggests that the results are exaggerated. It is not a question of exaggeration. The conclusion is simply wrong. The results do not support - at all - the conclusion that these young children were nicotine dependent.

The study reports that the measurement instrument was validated by testing it among a sample of smokers. Apparently, there was no testing conducted to see whether it makes any sense to use this scale among nonsmokers, whether nonsmokers will understand or have any idea how to answer questions that are not designed for them, and whether the ultimate result of the questioning will have any construct validity (i.e., whether it will actually correlate with nicotine dependence).

One could design a set of questions to assess the possibility of nicotine dependence among young nonsmokers, but these questions would not be on the list to try. They are leading questions which are not relevant to nonsmokers and whose use will ensure that nicotine dependence is found among nonsmokers.

In essence, this study was designed in such a way to create the very result it now reports. The study was set up such that it could not fail to find "nicotine dependence" among young nonsmokers. Furthermore, it was set up in such a way that it could not fail to find a correlation between "nicotine dependence" and secondhand smoke exposure.

Normally, I would assume that the intent of the researchers was pure and that setting up the study in this way was simply a bad mistake. However, the statement inserted into the paper about how these results are important in the movement to ban smoking in private cars with children leads me to believe that there is a strong bias inherent in this research and that the investigators are trying to find an association between secondhand smoke exposure and nicotine dependence, whether one exists or not.

This is an example of biased and shoddy science. Unfortunately, this is what tobacco control research is gradually deteriorating into. That the flaw inherent in this study is so blatant and that the results have already been disseminated worldwide in conclusive and striking fashion point to the damage that the degradation of the scientific integrity in tobacco control research is doing, not only to the movement, but to the public's appreciation of the scientific and medical facts about tobacco.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 25 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.